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The Irish Medicines Board - www.imb.ie

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New Applications

An application for a new Authorisation should be submitted to the Licensing Section of the Compliance Department of the IMB. 

Upon receipt of an application for a new Authorisation, an inspector will contact the company to ensure that the company is ready for an inspection.  An inspection will then be scheduled to take place at the facility.  On completion of an inspection, a recommendation for approval or rejection of the Authorisation application is referred to the Management Committee of the IMB.   

If approved, the appropriate Authorisation is drawn up and issued to the company. Where possible, this process has a maximum turnaround time of 90days.

If rejection is recommended by the Management Committee, the company is informed and given the right to appeal. Such appeals are dealt with in accordance with defined procedures.

For details on how to apply, and for details in relation to the fees for an Authorisation, please refer to the application form which can be found in the Publications section of this website. 


If you wish to contact the IMB with further questions on this topic please address your query to 
compliance@imb.ie


Date Printed: 17 May 2012

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